Kornimate/medical-research-clean huggingface dataset:
home-based training with feedback to improve outcomes in adolescents and young adults with cerebral palsy..

Conditions: Cerebral Palsy

Summary: this clinical trial aims to determine whether extrinsic feedback through music enhances the effects of home-based motor training for adolescents and young adults with cerebral palsy (cp) and whether feedback improves adherence to the training program. the main questions it aims to answer are: * does extrinsic feedback improve real-world movement more than home training alone? * do participants receiving extrinsic feedback adhere more closely to their training program? to determine its effectiveness, the investigators will compare home-based training with and without real-time music feedback. participants will: * engage in a home-based motor training program for 12 weeks, tailored to their individual needs and goals. * receive real-time music feedback during training or no feedback (control group). * attend weekly virtual coaching sessions to discuss short-term goals and training progress. * undergo movement assessments before training, at 12 weeks (t2) and 24 weeks (t3). * wear movement sensors for 72 hours at t2 and t3 to track real-world movement behavior.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cerebral palsy * sensorimotor deficits in at least one limb * demonstrated motivation to develop or regain motor skills, indicated by the expression of specific goals * ability to follow instructions independently or with caregiver support * ability to provide informed consent exclusion criteria: * diagnosis of dyskinetic cerebral palsy * presence of significant health risks that could interfere with participation * surgery or first botox injection within one month before the trial or during the trial period

Keywords: cerebral palsy home-based training extrinsic feedback movement behavior motor learning
visual outcomes for toric efficacy study

Conditions: Astigmatism; Myopia

Summary: this is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal contact lenses.


Eligibility criteria:
inclusion criteria: * 18 to 39 years of age (inclusive) * able to read and understand the study informed consent * plano to -5.00 d (inclusive) vertex corrected sphere power in each eye * 1.25 to -3.50 d (inclusive) vertex corrected astigmatism in each eye * best corrected acuity of 20/25 or better in each eye * no history of ocular pathology or surgery * no significant binocular vision or accommodation abnormality (i.e. strabismus, amblyopia) * no gas permeable lens wear for at least 1 month * no systemic or ocular contraindications for contact lens wear * not pregnant/lactating (by self-report) exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * prisoners * students for whom one of the principal investigators have direct access to/influence on grades would be consented and seen by another investigator for all visits. * pregnant/lactating women (by self-report)
multi point pacing vs. conventional study protocol

Conditions: Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy

Summary: the purpose of this study is to compare two programming modalities for crt devices in heart failure patients with an indication for cardiac resynchronization therapy


Eligibility criteria:
inclusion criteria: * patients with indication for crt (-p or -d) as per esc guidelines. ability to provide written informed consent. optimal medical therapy for at least 3 months exclusion criteria: * \< 18 years and younger * pregnant or breastfeeding patients * non-lbbb patients (rbbb, intra-ventricular delay) * non-ambulatory nyha class iv effort tolerance * myocardial infarction within 40 days before enrolment * cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months * atrial fibrillation (af) patients unless av node ablation is performed, or complete av block is present (to ensure optimal crt delivery) * patients with life expectancy of less than 12 months due to other medical conditions * patients who are involved in another investigational study (device or medical)
using micro electro mechanical systems to detect the air of vaginal discharge

Conditions: Vaginal Infection; Vaginitis

Summary: this clinical study aims to train the algorithm and assess the performance of the ainos flora women's vaginal health tester in identifying vaginal infections.

ainos flora women's vaginal health tester is an in vitro diagnostic device implementing electronic nose technology to detect vaginal infections by examining metabolized gases of vaginal bacteria. the electronic nose system mainly comprises the micro-electro-mechanical systems (mems) gas sensor array and the artificial neural network algorithm. the primary purpose of this study is to train the algorithm and assess the performance of the ainos flora in identifying vaginal infections. in addition, the primary outcome measures of this study, including sensitivity and specificity, will be used as a reference for the feasibility and sample size assessment of the next phase of pivotal clinical trials.

Eligibility criteria:
inclusion criteria: * female, age ≥20 to ≤50. * have had sexual experience. * fully understand the subject's informed consent process and be willing to undergo all study-related assessments and procedures. exclusion criteria: women who meet any of the following criteria by participant report will be excluded from the study: * during menstruation. * have performed vaginal washing within three days. * have been treated for vaginal infections within one week.

Keywords: e-nose
ketamine or placebo in patients with major depression and advanced cancer

Conditions: Major Depressive Disorder; Advanced Cancer

Summary: major depression (md) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1). md is a frequent complication in patients who are diagnosed with advanced cancer.


Eligibility criteria:
inclusion criteria: 1. age: 18 to 65 years of age 2. sex: male or female 3. major depressive disorder (mdd) diagnosis as per diagnostic and statistical manual of mental disorders (dsm-5). 4. palliative stage cancer diagnosis (advanced-disease stage) 5. who can read and write in spanish 6. eastern cooperative oncology group (ecog) 0-2 7. karnofsky ≥ 50 8. palliative prognostic index a 9. not currently undergoing systemic oncologic treatment 10. patients who agree to participate in the study by signing an informed consent. exclusion criteria: 1. comorbidities including other psychiatric diseases (additional to mdd, generalized anxiety or panic disorder). 2. magnetic resonance or computerized tomography with major structural alterations. 3. pregnant or breastfeeding women. 4. patients with hypersensitivity to ketamine 5. cardiac insufficiency 6. patients with a history of psychosis 7. patients with first-degree relatives with a history of psychosis 8. patients with uncontrolled glaucoma 9. current neurological illness
communication with in vitro fertilization (ivf) patients about risks

Conditions: Infertility

Summary: the primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (ivf). the main study hypothesis is that women and men who receive the study's educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of ivf, to compare perception of ivf-related risks to familiar risks that are included in routine preconception health promotion, and during ivf, and to prepare couples to manage ivf-related obstetrical risks when they make the transition to prenatal care after becoming pregnant. medical treatment coverage: none, this study does not provide any monetary contribution to medical treatment

the long-term objective of this research is to improve patient understanding of the known and strongly suspected risks from treating infertility with assisted reproductive technologies such as in vitro fertilization (ivf). during ivf, when more embryos are transferred to the uterus, the risk of pregnancy with multiple fetuses increases. in addition, single infants conceived with ivf are at greater risk for low birth weight. this study will promote behaviors that may reduce these risks. one in 3 women who completes a pregnancy conceived with assisted reproductive technologies such as ivf delivers multiples, and these treatments produce over 12,000 multiple birth deliveries annually in the united states. this study will lead to a better understanding of the most effective ways to counsel ivf patients about the embryo transfer decision. this study will also help define how to prepare ivf patients to work most effectively with their prenatal care team to manage ivf-related obstetrical risks. medical treatment coverage: none, this study does not provide any monetary contribution to medical treatment

Eligibility criteria:
inclusion criteria: * at least 18 years of age exclusion criteria: * using a gestational carrier in the current cycle of ivf

Keywords: infertility
efficacy of a combined transcranial direct current stimulation and virtual reality intervention

Conditions: Stroke; Hemiparesis; Chronic Stroke; Upper Limb Injury

Summary: rehabilitation options for stroke survivors who present severe hemiparesis in chronic stages are limited and may end in compensation techniques that involve the use of the less affected arm to achieve some degree of functional independence. transcranial direct current stimulation (tdcs) is a non-invasive technique that has been used after stroke to promote excitability of the surviving neural architecture in order to support functional recovery. interestingly, cortical excitability has been reported to increase when tdcs is combined with virtual reality. this synergetic effect could explain the promising results achieved by preliminary experimental interventions that combined both approaches on upper limb rehabilitation after stroke. the objective of this study is to explore the use of these interventions in subjects with severe hemiparesis and to determine its efficacy in comparison to conventional physical therapy


Eligibility criteria:
inclusion criteria: * chronicity \> six months * severe paresis of the upper limb defined by the brunnstrom approach as stages i or ii and by the upper extremity subscale of the fugl-meyer assessment as scores below 19 * ability to maintain a sitting position for at least 60 minutes * fairly good cognitive condition defined by scores in the mini-mental state examination above 23. exclusion criteria: * pacemakers * brain implants or other metallic objects (valves, coils, etc.) * impaired comprehension that hinder sufficient understanding of the instructions defined by mississippi aphasia screening test scores below 45 * severe visual impairments * emotional or behavioral circumstances that impede adequate collaboration

Keywords: virtual reality rehabilitation physical therapy
the effects of anaesthesia on cerebral oxygenation and cognitive function in carotid endarterectomy

Conditions: Endarterectomy; Postoperative Cognitive Dysfunction

Summary: volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via the mechanism known as a preconditioning. a transient deterioration of local hemodynamics and oxygenation during carotid endarterectomy (cee) might involve both hemispheres of brain and affect postoperative cognitive function. the goal of this study was to assess the effects of anesthetics on perioperative cerebral oxygenation and cognitive functions.

background: a transient deterioration of cerebral hemodynamics and oxygenation during cee might involve both hemispheres of the brain and affects postoperative cognition. despite some benefits of regional blocks, the majority of procedures of carotid endarterectomy (cee) are performed under general anaesthesia. surprisingly, the studies comparing the effects of sevoflurane and propofol on postoperative mental state in cee are scarce and controversial. while propofol possesses some anti-inflammatory properties, volatile anesthetics can interfere with cerebral blood flow and reperfusion-ischaemia injury via the mechanism of pre- and postconditioning. the goal of this study is to assess the effects of the anesthetics on the perioperative cerebral oxygenation and cognitive functions in cee. methods: the study and informed consent are approved by the ethical committee of the northern state medical university. forty patients (males only) who are to undergo elective cee will be included into a prospective study and randomised to two groups receiving either total intravenous anaesthesia (tiva group, propofol + fentanyl) or the volatile induction and maintenance of anaesthesia (vima group, n = 20, sevoflurane + fentanyl). all patients were operated using temporary carotid bypass. invasive arterial pressure (ap), gas exchange, and cerebral tissue oxygen saturation (scto2, foresight, casmed, usa) over frontal region for ipsilateral (scto2ipsi) and contralateral (scto2contr) hemispheres were registered during the surgery and up to 20 hrs of the postoperative period. the cognitive changes will be assessed at 12 hrs before as well as on days 1 and 5 after cee by blinded investigator using montreal cognitive assessment score (moca). data will be presented as median (25-75th percentiles). intergroup comparison will be provided with mann-whitney u-test and correlation analysis with spearman's coefficient (rho). p value below 0.05 was regarded as statistically significant.

Eligibility criteria:
inclusion criteria: * \> 18 years * male gender * informed consent * symptomatic carotid stenosis \> 75% exclusion criteria: * contralateral carotid occlusion * known allergy to the one of the compared medications

Keywords: carotid endarterectomy postoperative cognitive dysfunction
atomoxetine asian study in adult subjects with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv™) criteria for attention-deficit/hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. meet conners' adult adhd diagnostic interview for dsm-iv (caadid) diagnostic criteria for current adhd as well as meeting criteria for a historical diagnosis of adhd during childhood 3. have a clinical global impressions-adhd-severity (cgi-adhd-s) score of 4 (moderate symptoms) or greater exclusion criteria: 1. patients who meet dsm-iv diagnostic criteria for current major depression and also patients who have total score of more than 12 on the 17-item hamilton depression rating scale (hamd-17) at visit 1 and visit 2. patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of visit 1. 2. patients who meet dsm-iv diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited. 3. patients who have any history of bipolar disorder (dsm-iv) , any history of schizophrenia or any history of a psychotic disorder (dsm-iv) will be excluded from the study. 4. patients who have been diagnosed (dsm-iv) with a pervasive developmental disorder.
phagenyx® registry study

Conditions: Dysphagia

Summary: a retrospective, open-label, matched-control registry study designed to characterize the effectiveness of pharyngeal electrical stimulation (pes) to improve swallowing in patients with severe dysphagia post stroke when delivered using the phagenyx® system in real-world clinical settings in hospitals in the united states of america (us).

the study will consist of a treatment group and a control group. the treatment group will include patients who have undergone pes treatment for severe dysphagia. the control group will consist of patients that qualify for pes treatment but are not treated with pes in the time period prior to implementing pes. patients will be treated per standard of care at each institution. each treatment patient will receive treatment with pes in addition to other standard of care dysphagia therapies. control subjects will receive standard of care dysphagia therapies only (no pes or other electrical stimulation therapies for dysphagia are permitted). performance of the phagenyx® system will be analyzed by comparing treatment outcomes for patients in the pes group compared to patients in the control group. the study will include patients with severe dysphagia post stroke. the main clinical outcomes will be assessed using the participating sites' standard of care methodology and will evaluate improvements in swallowing and reduction in associated treatments and complications.

Eligibility criteria:
inclusion criteria: 1. phagenyx® system group patients: patients underwent treatment with the phagenyx® system for a minimum of 3 treatments. 2. control group patients: patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment. 3. willing and able to provide appropriate informed consent (if required). exclusion criteria: 1. primary endpoint outcome data not collected or not available. 2. in the investigator or sponsor's opinion the patient is not considered suitable. 3. participation in another interventional study (medicinal or device) that could influence the outcomes of pes. 4. treatment of dysphagia with other forms of electrical stimulation.
reintervention-study after previous renal denervation in non-responding patients with severe hypertension

Conditions: Hypertension, Resistant to Conventional Therapy

Summary: the purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. therefore ultrasound technique will be used.

renal denervation is a ce-certified opportunity for treating patients with therapy-refractory hypertension. in some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option. in this study repeated renal denervation will be performed with the recor paradise ultrasound catheter. for the study no specific procedures are required which would exceed the standard renal denervation procedure with the ce-certified recor paradise ultrasound catheter system. there are no additional risks for the patient in consequence of participating in the study or the follow up procedures.

Eligibility criteria:
inclusion criteria: * individual is ≥18 years old * individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention. * systolic office based blood pressure ≥140mmhg * individual receives 3 or more antihypertensive drugs including one diuretic * individual is willing to provide written informed consent to participate in this study exclusion criteria: * individual has hypertension secondary to an identifiable and treatable cause * individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation. * individual is pregnant, nursing or planning to be pregnant * renal artery abnormalities which may affect the procedure
forced-air warming in endovascular surgery: testing effectiveness of two different blanket models

Conditions: Hypothermia

Summary: prospective randomized trial comparing effectiveness of two different forced-air warming blankets in patients undergoing lower extremity angioplasty (lea) and endovascular abdominal aortic aneurysm repair (evar).

fifty patients undergoing lea and evar will be randomized into two groups: group upper body blanket and group underbody blanket. all patients will receive general anesthesia and body temperature will be measured and registered by an esophageal thermometer with 15 minutes interval beginning immediately after tracheal intubation up to tracheal extubation. the warming unit used (bair hugger 750 warming unit, arizant healthcare) will be the same for both groups and the blankets tested will be: upper body blanket (bair hugger 522 upper body blanket, 3m) and underbody blanket (bair hugger 635 full acess underbody blanket, 3m). surgical and anesthetic complications will be noted. only surgeries with minimum 45 minutes duration will be accepted for the purposes of this study.

Eligibility criteria:
inclusion criteria: * patients undergoing lea and evar * american society of anesthesiologists physical status (asa) : 1-4 exclusion criteria: * non-endovascular surgery * pregnant patients * patient refusal * less than 45 minutes duration of surgery

Keywords: forced-air warming hypothermia endovascular surgery blanket